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Package Leaflet: information for the use Warnings and precautions It is important that you tell your doctor if you are Talk to your doctor, nurse or pharmacist before taking breast-feeding or if you intend to breast-feed before ERTAPENEM 1 g ERTAPENEM. receiving ERTAPENEM. powder for concentrate for solution for infusion Women who are receiving ERTAPENEM should not During treatment, if you experience an allergic reaction breast-feed, because it has been found in human milk Ertapenem (such as swelling of the face, tongue or throat, difficulty and the breast-fed baby may therefore be affected. in breathing or swallowing, skin rash), tell your doctor Read all of this leaflet carefully before you straight away as you may need urgent medical are given this medicine because it contains Driving and using machines treatment. important information for you. Do not drive or use any tools or machines until you know how you react to the medicine. –– Keep this leaflet. You may need to read it again. While antibiotics including ERTAPENEM kill certain –– If you have any further questions, ask your Certain side effects, such as dizziness and sleepiness, bacteria, other bacteria and fungi may continue to have been reported with ERTAPENEM, which may doctor, nurse or pharmacist. grow more than normal. This is called overgrowth. –– This medicine has been prescribed for you only. affect some patients’ ability to drive or operate Your doctor will monitor you for overgrowth and treat machinery. Do not pass it on to others. It may harm them, you if necessary. even if their signs of illness are the same as ERTAPENEM contains sodium yours. It is important that you tell your doctor if you have This medicine contains approximately 6.0 mEq –– If you get any side effects, talk to your doctor, diarrhoea before, during or after your treatment (approximately 137 mg) of sodium per 1.0 g dose nurse or pharmacist. This includes any possible with ERTAPENEM. This is because you may have which should be taken into consideration by patients side effects not listed in this leaflet. See section 4. a condition known as colitis (an inflammation of the on a controlled sodium diet. bowel). Do not take any medicine to treat diarrhoea What is in this leafle without first checking with your doctor. 3. How to use ERTAPENEM 1. What ERTAPENEM is and what it is used for Tell your doctor if you are taking medicines called ERTAPENEM will always be prepared and given to 2. What you need to know before you are given valproic acid or sodium valproate (see Other you intravenously (into a vein) by a doctor or another ERTAPENEM medicines and ERTAPENEM below). 3. How to use ERTAPENEM healthcare professional. Tell your doctor about any medical condition you have 4. Possible side effects The recommended dose of ERTAPENEM for or have had including: 5. How to store ERTAPENEM adults and adolescents 13 years of age and older –– Kidney disease. It is particularly important that 6. Contents of the pack and other information is 1 gram (g) given once a day. The recommended your doctor knows if you have kidney disease and dose for children 3 months to 12 years of age is whether you undergo dialysis treatment. 1. What ERTAPENEM is and what it is used 15 mg/kg given twice daily (not to exceed 1 g/day). –– Allergies to any medicines, including antibiotics. Your doctor will decide how many days treatment for –– Central nervous system disorders, such as you need. localized tremors, or seizures. ERTAPENEM contains ertapenem which is an For prevention of surgical site infections following antibiotic of the beta-lactam group. It has the ability Children and adolescents (3 months to 17 years of surgery of the colon or rectum, the recommended to kill a wide range of bacteria (germs) that cause age) dose of ERTAPENEM is 1 g administered as a single infections in various parts of the body. Experience with ERTAPENEM is limited in children intravenous dose 1 hour before surgery. less than two years of age. In this age group your ERTAPENEM can be given to persons 3 months of doctor will decide on the potential benefit of its use. age and older. It is very important that you continue to receive There is no experience in children under 3 months of ERTAPENEM for as long as your doctor prescribes it. Treatment: age. Your doctor has prescribed ERTAPENEM because you If you are using more ERTAPENEM than you Other medicines and ERTAPENEM or your child has one (or more) of the following types should Always tell your doctor about all medicines that you of infection: If you are concerned that you may have been given are taking or plan to take, including those obtained • Infection in the abdomen too much ERTAPENEM, contact your doctor or without a prescription. • Infection affecting the lungs (pneumonia) another healthcare professional immediately. • Gynaecological infections Tell your doctor, nurse or pharmacist if you are taking If you forget to use ERTAPENEM • Skin infections of the foot in diabetic patients. medicines called valproic acid or sodium valproate If you are concerned that you may have missed a (used to treat epilepsy, bipolar disorder, migraines, Prevention: dose, contact your doctor or another healthcare or schizophrenia). This is because ERTAPENEM can • Prevention of surgical site infections in adults professional immediately. affect the way some other medicines work. Your doctor following surgery of the colon or rectum. will decide whether you should use ERTAPENEM in 4. Possible side effects combination with these other medicines. 2. What you need to know before you are Like all medicines, this medicine can cause side given ERTAPENEM Pregnancy and breast-feeding effects, although not everybody gets them. It is important that you tell your doctor if you are Adults 18 years of age and older: Do not use ERTAPENEM pregnant or are planning to become pregnant before –– if you are allergic to the active substance receiving ERTAPENEM. Since the drug has been marketed, severe allergic (ertapenem) or any of the other ingredients of this ERTAPENEM has not been studied in pregnant reactions (anaphylaxis), hypersensitivity syndromes medicine (listed in section 6) women. ERTAPENEM should not be used during (allergic reactions including rash, fever, abnormal –– if you are allergic to antibiotics such as penicillins, pregnancy unless your doctor decides the potential blood tests) have been reported. The first signs of a cephalosporins or carbapenems (which are used to benefit justifies the potential risk to the foetus. severe allergic reaction may include swelling of the treat various infections). ------The following information is intended for medical Reconstitution 10 mL from a 50 mL vial of sodium chloride 9 mg/mL or healthcare professionals only: Reconstitute the contents of a 1 g vial of ERTAPENEM (0.9 %) solution and discard. Transfer the contents of with 10 mL of water for injection or sodium chloride 9 the reconstituted 1g vial of ERTAPENEM to the 50 mL Instructions for use: mg/mL (0.9 %) solution to yield a reconstituted solution vial of sodium chloride 9 mg/mL (0.9 %) solution. For single use only. of approximately 100 mg/mL. Infusion Reconstituted solutions should be diluted in sodium Shake well to dissolve (See section 6.4). Infuse over a period of 30 minutes. chloride 9 mg/mL (0.9 %) solution immediately after preparation. Dilution Children (3 months to 12 years of age) For a 50 mL bag of diluent: For a 1 g dose, Preparation for intravenous administration: immediately transfer contents of the reconstituted vial Reconstitution ERTAPENEM must be reconstituted and then to a 50 mL bag of sodium chloride 9 mg/mL (0.9 %) Reconstitute the contents of a 1 g vial of ERTAPENEM diluted prior to administration. solution; or with 10 mL of water for injection or sodium chloride 9 For a 50 mL vial of diluent: For a 1 g dose, withdraw mg/mL (0.9 %) solution to yield a reconstituted solution Adults and adolescents (13 to 17 years of age) of approximately 100 mg/mL. Shake well to dissolve. face and/or throat. If these symptoms occur, tell your Children and adolescents (3 months to 17 years of What ERTAPENEM looks like and contents of the doctor straight away as you may need urgent medical age): pack treatment. ERTAPENEM is a white to off-white, freeze-dried Common (may affect up to 1 in 10 people) side effects powder for concentrate for solution for infusion. Common (may affect up to 1 in 10 people) are: Solutions of ERTAPENEM range from colourless to • Headache • Diarrhoea pale yellow. Variations of colour within this range do • Diarrhoea, nausea, vomiting • Diaper rash not affect potency. • Rash, itching • Pain at the infusion site • Problems with the vein into which the medicine is • Changes in white blood cell count ERTAPENEM is supplied in packs of 1 vial or 10 vials. given (including inflammation, formation of a lump, • Changes in liver function tests Not all pack sizes may be marketed. swelling at the injection site, or leaking of fluid into Rare (may affect up to 1 in 1 000 people) side effects the tissue and skin around the injection site) Marketing Authorisation Holder: • Increase in platelet count are: PANMEDICA • Changes in liver function tests • Headache 69/71, avenue Pierre Grenier • Hot flush, high blood pressure, red or purple, flat, 92100 Boulogne Billancourt Uncommon (may affect up to 1 in 100 people) pinhead spots under the skin France • Dizziness, sleepiness, sleeplessness, confusion, • Discoloured faeces, black tar-like faeces seizure • Skin redness, skin rash Manufacturer: • Low blood pressure, slow heart rate • Burning, itching, redness and warmth at infusion FACTA FARMACEUTICI S.p.A. • Shortness of breath, sore throat site, redness at injection site Nucleo Industriale S Atto • Constipation, yeast infection of the mouth, • Increase in platelet count S. Nicolo a tordino antibiotic-associated diarrhoea, acid regurgitation, • Changes in some laboratory blood tests 64100 TERAMO dry mouth, indigestion, loss of appetite ITALY • Skin redness Not known (frequency cannot be estimated from the available data) : • Vaginal discharge and irritation This medicinal product is authorized in the • Hallucinations • Abdominal pain, fatigue, fungal infection, fever, Member states of the EEA under the following • Altered mental status (including aggression) oedema/swelling, chest pain, abnormal taste names • Changes in some laboratory blood and urine tests Reporting of side effects This leaflet was last revised in July 2017 Rare (may affect up to 1 in 1 000 people) If you get any side effects, talk to your doctor, nurse • Decrease in white blood cells, decrease in blood or pharmacist. This includes any possible side effects platelet count not listed in this leaflet. You can also report side • Low blood sugar effects directly via Yellow Card Scheme Website: • Agitation, anxiety, depression, tremor www.mhra.gov.uk/yellowcard. By reporting side • Irregular heart rate, increased blood pressure, effects you can help provide more information on the bleeding, fast heart rate safety of this medicine. • Nasal congestion, cough, bleeding from the nose, pneumonia, abnormal breathing sounds, wheezing 5. How to store ERTAPENEM • Inflammation of the gall bladder, difficulty in Keep this medicine out of the sight and reach of swallowing, faecal incontinence, jaundice, liver children. disorder • Inflammation of the skin, fungal infection of the Do not use this medicine after the expiry date which skin, skin peeling, infection of the wound after an is stated on the carton and the vial. The expiry date operation refers to the last day of that month. • Muscle cramp, shoulder pain Do not store above 25°C. Store in the original • Urinary tract infection, kidney impairment package. • Miscarriage, genital bleeding • Allergy, feeling unwell, pelvic peritonitis, changes to Do not throw away any medicines via wastewater or the white part of the eye, fainting. household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures Not known (frequency cannot be estimated from the will help protect the environment. available data) • hallucinations Do not use this medicine if you notice particulate • decreased consciousness matter and/or discoloration prior to administration. • altered mental status (including aggression, delirium, disorientation, mental status changes) 6. Contents of the pack and other • abnormal movements information • muscle weakness • unsteady walking What ERTAPENEM contains • teeth staining The active ingredient of ERTAPENEM is ertapenem 1 g. There have also been reports of changes in some The other ingredients are: sodium hydrogen carbonate laboratory blood tests. and sodium hydroxide for pH adjustment. ------(See section 6.4). Compatibility of ERTAPENEM with intravenous From a microbiological point of view, the product Dilution solutions containing heparin sodium and potassium should be used immediately. If not used immediately, For a bag of diluent: Transfer a volume equal to 15 chloride has been demonstrated. in-use storage times and conditions prior to use are mg/kg of body weight (not to exceed 1 g/day) to a bag the responsibility of the user and would normally not of sodium chloride 9 mg/mL (0.9 %) solution for a final The reconstituted solutions should be inspected be longer than 24 hours at 2 to 8°C. concentration of 20 mg/mL or less; or visually for particulate matter and discolouration prior For a vial of diluent: Transfer a volume equal to 15 mg/ to administration. Reconstituted solutions range from Solutions should be used within 4 hours of their kg of body weight (not to exceed 1 g/day) to a vial of colourless to pale yellow. Variations of colour within removal from the refrigerator. Do not freeze solutions sodium chloride 9 mg/mL (0.9 %) solution for a final this range do not affect potency. of ERTAPENEM. concentration of 20 mg/mL or less. Chemical and physical in-use stability has been Any unused product or waste material should be Infusion demonstrated for 6 hours at 25°C and for 24 hours at disposed of in accordance with local requirements. Infuse over a period of 30 minutes. 2 to 8°C.